Kornimate/medical-research-clean huggingface dataset:
a study in healthy men to test how esomeprazole influences the amount of bi 1819479 in the blood

Conditions: Healthy

Summary: the main objective of this trial is to investigate the effect of the proton pump inhibitor esomeprazole on the pharmacokinetics of bi 1819479 in plasma.


Eligibility criteria:
inclusion criteria: * healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (bp), pulse rate (pr)), 12-lead electrocardiogram (ecg), and clinical laboratory tests * age of 18 to 55 years (inclusive) * body mass index (bmi) of 18.5 to 29.9 kg/m2 (inclusive) * signed and dated written informed consent in accordance with international council for harmonisation (ich) - good clinical practice (gcp) and local legislation prior to admission to the trial exclusion criteria: * any finding in the medical examination (including bp, pr or ecg) deviating from normal and assessed as clinically relevant by the investigator * repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre of mercury (mmhg), diastolic blood pressure outside the range of 50 to 90 mmhg, or pulse rate outside the range of 45 to 90 beats per minutes (bpm) * any laboratory value outside the reference range that the investigator considers to be of clinical relevance * any evidence of a concomitant disease assessed as clinically relevant by the investigator * gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders * cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair) * diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders * history of relevant orthostatic hypotension, fainting spells, or blackouts further exclusion criteria apply.
study the relationship between obesity and hepatitis c replication

Conditions: Hepatitis C

Summary: patients with chronic hepatitis c viral infection (hcv) and with a bmi greater than 25kg/m2 are refractory to medical treatment. also, hcv replication seems to be affected when modeling insulin resistance in replicon cell culture systems. pparg -agonist (pioglitazone) is effective in controlling liver inflammation in obese subjects with non-alcoholic steatohepatitis (nash) and also improving insulin sensitivity. therefore, we hypothesize that improving insulin resistance and /or inflammation may affect hcv replication and viral kinetics. independently of pparg pathways, prednisone may increase hcv viral kinetics. .

this is a randomized, two arm clinical trial. the investigators performing the primary and secondary endpoints are blinded to subject identifiers and arm identifiers. subject's screening for hcv genotype 4 started in agouza hospital in july 2010 and ended in february, 2011. no recruitment has occurred for hcv genotype 1.

Eligibility criteria:
inclusion criteria: * infection with hcv genotype 1 or 4 (subjects infected with multiple genotypes are not eligible) * bmi greater than 25 kg/m2 * hcv-infected subjects naïve to treatment: subjects who either have never been treated for hcv infection or who previously received hcv treatment ending more than 3 months prior to enrollment for not longer than 2 weeks * plasma hcv rna concentration of \>10,000 iu/ml at the screening evaluation exclusion criteria: * previous intolerance to pioglitazone, rosiglitazone, troglitazone or corticosteroids * women who are pregnant or breastfeeding * history of diabetes mellitus requiring treatment other than diet * decompensated liver disease or other known causes of liver disease including, but not limited to autoimmune hepatitis, wilson's disease, hemochromatosis, primary biliary cirrhosis, schistosomiasis, sclerosing cholangitis, alcohol- or drug-induced liver disease, or alpha-one antitrypsin deficiency * concurrent hepatitis b virus (hbv) infection * known immunodeficiency disease, autoimmune disorders or active gastrointestinal disease * abuse of alcohol or illicit drugs within 6 months before enrollment * use of an investigational drug within 4 weeks before the screening visit or during the screening period. * use of systemic immunosuppressants * history of poorly controlled psychiatric disease or poorly controlled pulmonary disease
evaluation of the serum soluble fractalkine as a biomarker of pulmonary fibrosis in systemic sclerosis

Conditions: Systemic Scleroderma

Summary: systemic scleroderma (scs) is an autoimmune disease characterized by vascular involvement, a dysimmune condition, cutaneous and visceral fibrosis. interstitial lung disease (ild) affects 75% of ssc patients and is the leading cause of death in ssc. no diagnostic or prognostic biomarkers of ssc-associated ild have been validated to date. the search for such a serum biomarker is essential to assess the severity of these patients and to help the therapeutic management. we have shown that soluble fractalkine is elevated in ssc patients, especially in ssc patients with ild. the fractalkine is both an endothelial adhesion molecule and a chemokine that binds to the cx3cr1 receptor expressed by immune populations. it would thus reflect the vasculopathy and inflammation that lead to the fibrosing pulmonary involvement of this disease. objectives and means: we aim to perform a low-risk interventional biomedical research which main objective is the quantitative evaluation of soluble fractalkine in ssc patients with ild in comparison with ssc patients without ild. this epidemiological, explanatory, analytical, single-center study will comprise three groups: 1 / ssc without ild (control group in the context of ssc), 2/ ssc with ild and 3/ patients with idiopathic pulmonary fibrosis (ipf) (control group of the ild). secondary objectives are evaluation of: 1 / fractalkine levels in the ipf, 2 / correlations between fractalkine levels and severity of ild and of ssc disease over time, 3 / correlations between fractalkine and 2 other biomarkers: kl-6 (marker of pulmonary fibrosis) and soluble cd146 (scd146, marker of vasculopathy), 4 / predictive values of the decline in lung function of these 3 markers.


Eligibility criteria:
inclusion criteria: * patients over the age of 18 with ssc with or without ild with a medical follow up in ap-hm * patients, followed at ap-hm, with ipf exclusion criteria: * impossibility of taking blood * known diagnosis of respiratory disorders other than ssc-associated ild and ipf * an infection in progress * an evolutive cancer * chemotherapy or radiation therapy in progress * minors * pregnant or lactating women * majors under guardianship * people staying in a health or social facility * people in emergency * non-beneficiaries of a social security scheme * persons deprived of their liberty
nbi with magnification for dysplasia detection in ulcerative colitis

Conditions: Ulcerative Colitis

Summary: the purpose of the study is to determine whether a new colonoscopic viewing technique called narrow band imaging (nbi) helps doctors detect more patients with at leat one pre-cancerous area (dysplasia associated lession or mass, malms) than conventional colonoscopy using white light alone.

colorectal cancer is the second commonest cause of cancer death. patients with colitis have a substantially increased risk of death from colorectal cancer which increases with lenght of time the patient has had colitis. this can be as high as a 30% chance of colorectal cancer after 30 years of colitis. colonoscopic surveillance of colitis patients has been shown to reduce the risk of colorectal cancer and allow detection at an earlier stage, but even with meticulous examination, some precancerous lesions or cancers are missed. precancerous lesions in colitis are difficult to see and endoscopist have used spraying dye on the lining of the bowel (chromoendoscopy) successfully to improve detection of abnormal areas: however this is time consuming and requires extra time and equipment and despite the benefits seen in multiple studies is not widely used in routine clinical practice in the uk. narrow band imaging (nbi) is a technique that relies on light filters to improve contrast for the smallest blood vessels in the bowel lining which shows up precancerous areas as they have a richer vascular network. it is sometimes described as "digital chromoendoscopy" as the images produced are similar to chromoendoscopy, but it is much simpler and quicker to use. with magnification it allows assessment of the fine mucosal surface pattern (pit pattern) of lesion which allows and assessment of their likelihood of being precancerous. autofluorescence endoscopy uses short wavelength light and light filters to produce a false colour image of the bowel lining where polyps stand out. these techniques have been used with some success in the oesophagus and stomach but little work is available for the colon. we aim to see if nbi with magnification is better that standard colonoscopy for detecting precancerous areas. this is likely as it produces images similar to chromoendoscopy which is already shown to help. if a potentially precancerous area is found we will use other types of endoscopy, particularly nbi autofluorescence to see if these techniques are helpful for discriminating between pre-cancerous and non pre-cancerous areas

Eligibility criteria:
inclusion criteria: * petients with colitis who meet surveillance criteria * patients over 18 years of age exclusion criteria: * pregnant patients * unable or unwilling to give informed consent * patients with severe active colitis who would be unsafe to endoscope

Keywords: colonoscopy, narrow band imaging (nbi), ulcerative colitis
the effect of oliceridine patient-controlled intravenous analgesia on postoperative chronic pain after video-assisted thoracoscopic lobectomy

Conditions: Chronic Postsurgical Pain

Summary: the primary objective is to evaluate the impact of oliceridine versus sufentanil for perioperative analgesia on the incidence of chronic postsurgical pain (cpsp) in patients undergoing video-assisted thoracoscopic surgery.

the primary objective is to evaluate the impact of oliceridine administered via patient controlled analgesia device（pca）versus sufentanil administered via pca on the incidence of chronic postsurgical pain (cpsp) in patients undergoing video-assisted thoracoscopic surgery.

Eligibility criteria:
inclusion criteria: * ① age 18-75 years, asa physical status i-iii, bmi 18-30 kg/m²; * scheduled for unilateral video-assisted thoracoscopic surgery (vats) lung resection, including wedge resection, segmentectomy, lobectomy, or radical resection for lung cancer; * preoperative pain score \<1 on the numeric rating scale (nrs); * ability to understand the study objectives and procedures, with voluntary informed consent obtained; * expected postoperative recovery in the general ward setting. exclusion criteria: * ① history of chronic pain or long-term analgesic use prior to surgery; * previous ipsilateral thoracic surgery; * prior neoadjuvant radiotherapy or chemotherapy; * severe cardiovascular or cerebrovascular disease, or hepatic/renal dysfunction (alt/ast \>3× upper limit of normal; egfr \<60 ml/min/1.73m²); * concurrent malignancy or active infection; * pre-existing psychiatric disorders or communication barriers precluding study participation; * known hypersensitivity to study medications (opioids, adjuvant analgesics, anesthetics, or antiemetics); * any condition deemed unsuitable for study participation by the investigator
primary prevention of cardiovascular disease (cvd) in pre-diabetic & pre-hypertensive subjects

Conditions: Pre-diabetes; Pre-hypertension

Summary: the purpose of this study is to determine whether treating pre-diabetic \& pre-hypertensive individuals using multiple drugs intervention (anti-hypertensive drugs (i.e., acei) plus anti-glycemic drug (i.e., metformin) plus anti-hyperlipidemic drug (statin)) would lower cardiovascular disease (cvd) events.

the risks of cvd are not confined to a subset of established "hypertensive" or "diabetic" population, but also increase among those with suboptimal blood pressure and glycemic level, namely "pre-hypertensive" or "pre-diabetic" population. evidence on the effectiveness of drug interventions to lower cvd events in pre-clinical stage population has been scant.

Eligibility criteria:
inclusion criteria: * pre-diabetes * pre-hypertensives * ldl-cholesterol \>= 100 \< 190 mg/dl * bmi \>= 23 * estimated gfr \>= 60 ml/min/1.73 m2 (mdrd equation) * willing to participate and provide written inform consent exclusion criteria: * current involved in other studied medications * regular use of corticosteroids * current use of weight loss medication * history of renal disease * active liver disease including jaundice, chronic hepatitis with alt \>= 2.5 the upper normal limit * active malignancy * major psychiatric disorder * diseases and medications that affect glucose tolerance (e.g. pheochromocytoma, cushing's syndrome, acromegaly, steroid-dependent asthma, protease inhibitors, antipsychotics) * nursing women, pregnant women, or those that plan to become pregnant in the study period

Keywords: impaired fasting glucose impaired glucose tolerance pre-diabetes pre-hypertensives cardiovascular events
stereotactic management of arrhythmia - radiosurgery treatment and evaluation of response in ventricular tachycardia

Conditions: Ventricular Tachycardia

Summary: prospective single-arm study investigating the efficacy and safety of non-invasive cardiac radiosurgery for the treatment of ventricular tachycardia (vt) with reduced dose of radiation (20 gy). the efficacy and safety outcome measures will be compared with historical control - patients treated within the smart-vt study (nct04642963) with a single dose of 25 gy to test the hypothesis that reduced dose of radiation is similarly effective in terms of reduction of vt burden.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * patients with structural heart disease * patients with implantable cardioverter defibrillator (icd) or cardiac resynchronization therapy with defibrillation (crt-d) * clinically symptomatic ventricular arrhythmia despite adequate treatment, with episodes of ventricular tachycardia occurring at least 3 times per month * at least one episode of monomorphic ventricular tachycardia recorded during an electrophysiological examination * recurrent vt despite at least one previous failed attempt at percutaneous ablation or disqualification from this treatment method (eg, patients after percutaneous closure of patent foramen ovale, ventricular septal defect). * persistent recurrence of vt despite adequate pharmacotherapy. * informed consent of the patient to participate in the study. exclusion criteria: * premature ventricular contractions * cardiac damage requiring inotropic treatment * implantation of left ventricular assist device (lvad) * ventricular arrhythmia in the course of channelopathy * reversible cause of vt * new york heart association (nyha) stage iv heart failure * myocardial infarction or cardiac surgery in the last 3 months. * life expectancy less than 6 months * polymorphic ventricular tachycardia * pregnancy or breastfeeding * substrate location that prevents safe radiotherapy (eg due to location relative to critical organs, or dose given during previous radiotherapy treatments). * evidence of an active systemic, pulmonary or pericardial inflammatory process that has required systemic treatment in the past 6 months (eg disease-modifying drugs, steroids, immunosuppressants). patients treated for sarcoidosis who are currently in remission on chronic immunosuppressive drugs, without current signs of an acute inflammatory process, may be included in the study. * active, uncontrolled malignancy and/or chemo/immunotherapy in the past month or planned within the month following radioablation. * lack of the informed consent

Keywords: radioablation stereotactic arrhythmia radioablation (star) stereotactic body radiotherapy (sbrt) ventricular tachycardia
an study to evaluate rosuvastatin in children and adolescents with familial hypercholesterolaemia

Conditions: Familial Hypercholesterolaemia

Summary: this study is being carried out to see if the study medication, rosuvastatin, is effective in treating familial hypercholesterolaemia in children and adolescents, and to determine the long term (over 2 years) safety, tolerability and efficacy of the study medication in these patients. this study will also measure levels of drug in the blood and see how well it is tolerated. this is known as pharmacokinetic (pk) analysis. at baseline only a small number of patients will participate in a single dose pk phase over 24 hours. in order to see if this medication works, a control group of healthy siblings will help the researchers to compare certain results.


Eligibility criteria:
inclusion criteria: * children and adolescents (aged 6 to less than 18 years) with familial hypercholesterolaemia * patients aged between 6 and less than 10 years of age must not be taking a statin medicine exclusion criteria: * history of muscle or sensitivity reactions to any statin medicines * current active liver disease or dysfunction (except a confirmed diagnosis of gilbert's disease)

Keywords: familial hypercholesterolaemia pediatric
hydroxychloroquine in blocking autophagy in patients with prostate cancer undergoing surgery or active surveillance

Conditions: Prostate Carcinoma

Summary: this phase 0 trial studies hydroxychloroquine in blocking autophagy in patients with prostate cancer who are undergoing surgery or active surveillance. autophagy is a process in which cells break down some parts of themselves to stay alive during times of stress, such as starvation. this may allow cancer cells to survive damage from chemotherapy. hydroxychloroquine may block this process from happening.

primary objectives: i. to determine the effect of different doses of hydroxychloroquine on markers of autophagy in prostate tumor. secondary objectives: i. to determine the distribution of autophagic activity within prostate cancer tissue. ii. to determine the utility of beclin-1 as a marker of autophagic activity. iii. to assess markers of apoptosis in tumor tissue. iv. to perform deep-sequencing on prostate tissue obtained at the time of surgery. v. to assess prostate-specific antigen (psa) as a biochemical endpoint of clinical activity. vi. to determine the number of circulating tumor cells (ctcs) in pre- and post-treatment blood samples. outline: patients are assigned to 1 of 2 groups. group i (planning prostatectomy): patients in group i are randomized to 1 of 2 arms. arm i: patients receive hydroxychloroquine orally (po) once daily (qd) for 14 days and then undergo prostatectomy. arm ii: patients receive a higher dose of hydroxychloroquine po thrice daily (tid) for 14 days and then undergo prostatectomy. group ii (active surveillance): patients receive hydroxychloroquine po qd. treatment continues until the beginning of local therapy or for up to 1 year.

Eligibility criteria:
inclusion criteria: * signed written informed consent * have abnormal digital rectal examination, or abnormal prostate specific antigen (\> 4.0 ng/ml), or obstructing prostate, or biopsy proven prostate cancer * scheduled for prostate surgery, i.e. transurethral resection of the prostate (turp) or prostatectomy * planned to be treated by active surveillance exclusion criteria: * patients on treatment for rheumatoid arthritis or systemic lupus erythematosus * patients with psoriasis * patients receiving any disease-modifying anti-rheumatic drug (dmard) * active clinically significant infection requiring antibiotics * patients with glucose-6-phosphate dehydrogenase (g6pd) deficiency * patients taking other commercially available medications which may theoretically either stimulate or inhibit autophagy, which are calcitriol and chloroquine * patients taking medications which may lead to interactions with hydroxychloroquine, including penicillamine, telbivudine, botulinum toxin, digoxin, and propafenone * patients must not have prior visual field changes from prior 4-aminoquinoline compound use * must not be taking hydroxychloroquine for treatment or prophylaxis of malaria * history of hypersensitivity to 4-aminoquinoline compound
lymph node counts in endometrial cancer staging

Conditions: Endometrial Cancer

Summary: the purposes of this study are to determine whether total lymph node count or the percentage of identified nodes with metastatic disease are influenced by (1) the method of categorizing tissue specimens or (2) the techniques of pathologic processing following lymphadenectomy. patients with newly diagnosed endometrial carcinoma of high risk histologic type or uterine carcinosarcoma whose risk of ln metastasis exceeds 15% will be enrolled on this study. patients will undergo staging to include hysterectomy and selective lymphadenectomy as per the clinical judgment of the primary gynecologic oncologist. type of hysterectomy and the extent and distribution of lymphadenectomy is at the discretion of the surgeon. all patients will be scheduled for surgical staging. each subject will have lymph nodes harvested on one side divided into specific basins, and on the contralateral side classified only as "pelvic" or "aortic". surgical node specimens in the operating room will be labeled by (1) specific nodal basins on the randomly determined side as "external iliac", "obturator", "common iliac", "aortic", or "high aortic" and by (2) "pelvic" versus "aortic" (common iliac nodes will be considered as part of the "pelvic" specimen) on the contralateral side.


Eligibility criteria:
inclusion criteria: * uterine cancer with one of the following pathologies: serous, clear cell, sarcoma or grade 3 differentiation * surgical candidate exclusion criteria: -